Indications for Cabozantinib in Advanced RCC Expanded to First-line Therapy

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Cabozantinib previously received FDA approval for pretreated advanced RCC.
Cabozantinib previously received FDA approval for pretreated advanced RCC.

The US Food and Drug Administration (FDA) granted regular approval to cabozantinib as a first-line therapy for patients with advanced renal cell carcinoma (RCC).1

The drug, which inhibits multiple tyrosine kinases, was previously approved for pretreated advanced RCC.

The FDA based its approval on data from the open-label, phase 2 CABOSUN study ( Identifier: NCT01835158), for which researchers randomly assigned 157 patients with RCC to receive oral cabozantinib 60 mg daily or sunitinib 50 mg daily for 4 weeks on, then 2 weeks off. Patients had been diagnosed with intermediate- or poor-risk RCC.

Median progression-free survival was 8.6 months (95% CI, 6.8-14.0) vs 5.3 months (95% CI, 3.0-8.2) for patients in the cabozantinib arm vs the sunitinib arm, respectively (hazard ratio [HR], 0.48; 95% CI, 0.31-0.74; P = .0008).2

Patients in the cabozantinib arm had an overall response rate (ORR) of 33% (95% CI, 23%-44%) compared with 12% (95% CI, 5.4%-21%) in the sunitinib arm.

The most frequently reported grade 3 to 4 adverse events included hypertension, hypotension, syncope, diarrhea hypophosphatemia, hyponatremia, fatigue, stomatitis, pain, and decreased appetite.


  1. FDA grants regular approval to Cabometyx for first-line treatment of advanced renal cell carcinoma [news release]. Silver Spring, MD: US Food and Drug Administration; December 19, 2017. Accessed December 20, 2017.
  2. Choueiri TK, Halabi S, Sanford BL, et al. Cabozantinib vs sunitinib as initial targeted therapy for patients with metastatic renal cell carcinoma of poor or intermediate risk: the Alliance A031203 CABOSUN trial. J Clin Oncol. 2017;35(6):591-7. doi: 10.1200/JCO.2016.70.7398
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